Apparatus and methods for tracking administering of medication by syringe

ABSTRACT

An apparatus and methods for tracking administering of medication by syringes is provided. The apparatus may include a plunger head for a syringe. The plunger head may include a transducer that sends and receives ultrasonic signals. The plunger may also include an antenna and a microcontroller that interfaces with the transducer and the antenna. The plunger may also include a power source that powers the microcontroller and the transducer. The transducer, the antenna, the microcontroller, and the power source may be at least partially encapsulated in an elastomer housing that fits within a barrel of the syringe. The microcontroller may be programmed with instructions to calculate data representative of the quantity of medication dispensed from the barrel and transmit the data to a remote device via the antenna.

RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.15/827,402, filed Nov. 30, 2017, which is a divisional of and claims thebenefit of U.S. application Ser. No. 15/133,396, filed Apr. 20, 2016,which claims the benefit of U.S. Provisional Application No. 62/305,067,filed Mar. 8, 2016, all of which are incorporated by reference in theirentirety.

BACKGROUND Technical Field

The present disclosure relates generally to the field of trackingadministering of medication, and more particularly, apparatus andmethods for tracking administering of medication by syringes.

Background Description

Measuring the quantity and recording the timing of a drug'sadministration is an integral part of many disease treatments. For manytreatments, to achieve the best therapeutic effect, specific quantitiesof a drug may need to be injected specific times of day. For example,individuals suffering from diabetes may be required to inject themselvesregularly throughout the day in response to measurements of their bloodglucose. The frequency and volume of insulin injections must becarefully tracked and controlled to keep the patient's blood glucoselevel within a healthy range. Currently, there are a limited number ofmethods or devices for automatically tracking the drug administrationwithout requiring the user to manually measure and record the volume,date, and time. A variety of glucose injection syringes/pens have beendeveloped, but there is much room for significant advancement in thetechnology in order to reduce the size, lower the cost, and enhanced thefunctionality thus making them a more viable long term solution. Forexample, current insulin pens are often disposable, but do not includedosage tracking. A smaller portion of the market is composed of reusablepens which are more expensive, and still don't include good dosagetracking capabilities.

SUMMARY

The present disclosure is directed to systems and methods of drugadministration using a syringe with a smart plunger head.

In one aspect, the present disclosure is directed to a plunger head fora syringe. The plunger head may include a transducer that sends andreceives ultrasonic signals. The plunger may also include an antenna anda microcontroller that interfaces with the transducer and the antenna.The plunger may also include a power source that powers themicrocontroller and the transducer. The transducer, the antenna, themicrocontroller, and the power source may be at least partiallyencapsulated in an elastomer housing that fits within a barrel of thesyringe. The microcontroller may be programmed with instructions tocalculate data representative of the quantity of medication dispensedfrom the barrel and transmit the data to a remote device via theantenna.

In another aspect, the present disclosure is directed to a system fortracking administering of a medication dispensed by a syringe. Thesystem may include a plunger head that fits within a barrel of thesyringe. The plunger head may include a transducer that sends andreceives ultrasonic signals and a first antenna. The plunger head mayalso include a first microcontroller that interfaces with the transducerand the antenna. The system may also include a cuff that is attachableto the barrel of the syringe. The cuff may include a secondmicrocontroller, a second antenna that receives information from theplunger head via the first antenna, and a power source. The firstmicrocontroller may be programmed with instructions to measure the timeit takes for the ultrasonic signals to travel through the medication inthe syringe to an end of the barrel and return to the transducer, thesecond microcontroller may be programmed with instructions to calculatedata representative of the quantity of medication dispensed from thebarrel based on a change in the time measured.

In another aspect, the present disclosure is directed to a method oftracking administering of a medication delivered by syringe. The methodmay include depressing a plunger of the syringe. The method may alsoinclude sending and receiving ultrasonic signals from a plunger headinstalled within a barrel of the syringe. The method may further includemeasuring the time it takes for the signals to travel through themedication to an end of the barrel and return to the transducer. Themethod may also include calculating the distance the plunger headtravels based on a change in the time and calculating a quantity of themedication dispensed based on the distance the plunger head travels. Themethod may further include selectively transmitting wirelessly thequantity of the medication dispensed to a remote device.

In another aspect, the present disclosure is directed to a plunger headfor a medication injection device. The plunger head may include atransducer that sends and receives ultrasonic signals and an antenna.The plunger head may also include a microcontroller that interfaces withthe transducer and the antenna, and a power source that powers themicrocontroller and the transducer. The transducer, the antenna, themicrocontroller, and the power source may be at least partiallyencapsulated in an elastomer housing that fits within a barrel of themedication injection device. The microcontroller may be programmed withinstructions to calculate data representative of the quantity ofmedication dispensed from the barrel and transmit the data to a remotedevice via the antenna.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a syringe, which includes a plunger headaccording to an exemplary embodiment.

FIG. 2 is a schematic of the plunger head of FIG. 1.

FIG. 3 is a schematic illustrating the behavior of ultrasonic signalstransmitted by the plunger head of FIG. 2.

FIG. 4 is a perspective view of a syringe, which includes a plunger headand a cuff according to an exemplary embodiment.

FIG. 5 is a flow chart illustrating a method of tracking administeringof medication by syringe, according to an exemplary embodiment.

DETAILED DESCRIPTION

Reference will now be made in detail to embodiments of the presentdisclosure, examples of which are illustrated in the accompanyingdrawings. Where possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

FIG. 1 shows a perspective view of a syringe 10 designed for ejecting afluid. Syringe 10 may include a barrel 12, a plunger 14, a needle 16,and a hub 18 connecting needle 16 to barrel 12. Barrel 12 may beconfigured to contain a fluid, for example, a medication 20 and syringe10 may be configured to dispense medication 20 from needle 16 whenplunger 14 is depressed. A standard syringes usually contains a plungerhead at the end of the plunger that seals the top of the barrel andforces the fluid out the needle when the plunger is depressed. Theplunger head for a standard syringe is usually just a piece of moldedplastic.

For Syringe 10 shown in FIG. 1, the standard plunger head has beenreplaced with a smart or intelligent plunger head 22 that is configuredto measure and register the quantity of medication 20 administered andthe date and time of administration. Plunger head 22 may be installed ina standard syringe by withdrawing plunger 14 and removing the standardplunger head and installing smart plunger head 22. In some embodiments,syringe 10 may be manufactured and supplied with a smart plunger head 22preinstalled. Smart plunger head 22 may be referred herein as eithersmart plunger head 22 or plunger head 22.

Plunger head 22 may be sized to correspond with the size of barrel 12.For example, plunger head 22 may be formed to fit any size syringe. Forexample, plunger head 22 may be sized to fit a 1 ml, 2 ml, 3 ml, 5 ml,10 ml, 20 ml, 30 ml, or 50 ml syringe.

FIG. 2 shows a schematic of plunger head 22, according to an exemplaryembodiment. Plunger head 22 may include a transducer 24, amicrocontroller 26, a power source 28, and an antenna (e.g., for nearfield communication (NFC) or a transceiver 30 (e.g., for BLUETOOTH lowenergy (BLE) communication). In some embodiments, the components ofplunger head 22 may be at least partially encapsulated in an elastomer(e.g., rubber, ethylene propylene (EPM), Nitrile (NBR), ethylenepropylene diene (EPDM), polybutadiene, and polyisoprene). Transducer 24may be configured to send and receive ultrasonic signals.Microcontroller 26 may be programmed with instructions to control theoverall operation of the plunger head. Transceiver 30 may be configuredto wirelessly communication with a remote device (e.g., a smart phone, aglucose monitor, an insulin pump, and a computer) using one or morewireless communication methods. The one or more wireless communicationmethods may include, for example, radio data transmission, Bluetooth,(BLE), (NFC), infrared data transmission, electromagnetic inductiontransmission, and/or other suitable electromagnetic, acoustic, oroptical transmission methods. Power source 28 may be configured to powertransducer 24, microcontroller 26, and transceiver 30.

Transducer 24 may be an actuator, piezoelectric element, or speaker-likevoice coil configured to generate and send a pressure wave or ultrasonicsignal. Transducer 24 may be sized to be slightly smaller than the innerdiameter of barrel 12. As shown in FIG. 3, transducer 24 may beconfigured to generate ultrasonic signals 25 (e.g., radiated soundenergy waves) and send the ultrasonic signals 25 down barrel 12 towardhub 18 and needle 16. The ultrasonic signals can travel throughmedication 20 along the length of barrel 12 and bounce or reflect off anend 27 of barrel 12 and travel back through medication 20 to plungerhead 22. The reflected ultrasonic signals can be received and detectedby transducer 24. The speed of sound in medication 20 may be a knownvalue and thus a distance D can be calculated very accurately based onthe time it takes for a ultrasonic signal to travel down and back fromtransducer 24. As plunger head 22 is moved down barrel 12 distance Dwill change and by knowing the diameter of barrel 12 then the volume ofmedication 20 dispensed may be calculated based on the change indistance D.

In some embodiments a portion of the transducer 24 may make directphysical contact with medication 20 (e.g., for the best impedancematching). For embodiments where transducer 24 makes direct contact withmedication 20, transducer 24 may be coated to prevent chemicalinteractions or to improve mechanical impedance matching between thetransducer and medication 20. In some embodiments, transducer 24 may bemolded directly into the material (e.g., elastomer) of the plunger head22. It is contemplated that there are a variety of configures formaximizing the transfer of ultrasonic signals 25 from transducer 24 tomedication 20 and from medication 20 to transducer 24.

In some embodiments, transducer 24 may be configured to vibrate in orderto numb the needle injection site so that the pain is reduced.

As shown in FIG. 3, in some embodiments, a porous membrane 29 may beplaced within barrel 12 at end 27. Porous membrane 29 may be designed toallow medication 20 to pass through while providing a surface with goodreflective properties for the ultrasonic signals 25 to reflect from.Utilizing porous membrane 29 may improve the accuracy of the reflectivewave detection and thereby the distance and volume calculations. It iscontemplated that other materials may be used besides a porous membrane.It is also contemplated that the geometry of barrel 12 at end 27 maydictate whether a porous membrane is needed. For example, in someembodiments the geometry of end 27 may be designed to produce thedesired reflective properties avoiding the need to porous membrane 29.

Microcontroller 26 may include one or more processors, including forexample, a central processing unit (CPU). The processors may include anysuitable type of commercially available processor or may be a customdesign. Microcontroller 26 may include additional components, forexample, non-volatile memory (e.g., a flash memory), volatile memory(e.g., a random access memory (RAM)), and other like components,configured to store information).

Microcontroller 26 may be programmed with instructions to control theoperation of transducer 24. Microcontroller 26 may be programmed withinstructions to calculate data representative of the quantity ofmedication 20 dispensed. For example, in some embodiments,microcontroller 26 may be programmed to detect and record the reflectiontimes of the ultrasonic signals 25. Based on the reflection times,microcontroller 26 may track and produce a time profile of the distancebetween transducer 24 (i.e., plunger head 22) and end 27. Based on thetime profile of the distance, microcontroller 26 may be able to identifya first distance D₁ or starting position (e.g., before medication 20 isdispensed), which may correspond with barrel 12 being filed and a seconddistance D₂ or ending position (e.g., after medication 20 is dispensed),which may correspond with barrel 12 being empty. Microcontroller 26 maythen calculate the change in distance between D₁ and D₂ and based off ofthe change in distance may calculate the volume (i.e., amount orquantity) of medication 20 dispensed.

In some embodiments, medication 20 may include an active medicationingredient and a buffer solution. The concentration of the activemedication ingredient may be known or programmed into microcontroller 26enabling the specific volume of the active medication ingredient to becalculated. In some embodiments, for example, the concentration of theactive medication ingredient may be stored in the non-volatile memory ofmicrocontroller 26. In some embodiments, additional informationregarding the medication 20 may also be stored, for example, ultrasonicvelocity vs. temperature data.

In some embodiments, in addition to calculating the volume of medication20 as it is dispensed, plunger head 22 may first calculate the volume ofmedication 20 while it was initially loaded into syringe 10. Forexample, in some embodiments, plunger head 22 may send and receiveultrasonic signals while medication 20 is being drawn into barrel 12.Calculating both the volume of medication 20 as it is loaded anddispensed can act as a verification or double check.

Transducer 24 and/or microcontroller 26 may be programmed to performvarious forms of signal conditioning in order to detect the time of thereflected ultrasonic signals 25. The signal conditioning may include,for example, amplification, filters, and envelope detection. Transducer24 and/or microcontroller 26 may use the signal conditioning todetermine for example, time to first rising edge or time to maximumreflective value in order to determine the reflection time.

Plunger head 22 may transmit the amount of medication 20 dispensed alongwith the time and date it was dispensed to a remote device (e.g., asmart phone, a glucose monitor, an insulin pump, and a computer) via oneor more of the wireless communication methods. Plunger head 22 may havea unique identifier so the remote device may be able to identify andprocess the information received properly. Plunger head 22 may transmitthis information to the remote device immediately or shortly after themedication is administered or plunger head 22 may store the informationuntil the remote device is within range. The information may be stored,for example, in memory of microcontroller 26. In some embodiments,plunger head 22 may wait to initiate transmitting of the information tothe remote device until initiated by the remote device. For example, auser may initiate information retrieval on the remote device. In someembodiments, the remote device may transmit the information to acaregiver (e.g., a doctor) or upload the information to the cloud so itmay be saved to the patient's medical history and may be accessed by thecaregiver. The ability of a caregiver or a patient to access and reviewthe dose history may improve treatment. For example, the ability of acaregiver to review a diabetic insulin injection history and continuousglucose measurement data may enable the caregiver to adjust theprescribe treatment to improve the therapeutic effect, for example, bybetter stabilizing the patients glucose levels.

In some embodiments, microcontroller 26 may be configured to simplydetect the reflection time of the ultrasonic signals 25 and transmitthat to the remote device and the remote device may perform all thecalculations. For example, in some embodiments, plunger head 22 may be apassive device (e.g., battery free) and the remote device may utilizenear field communication (NFC) to control microcontroller 26 andtransducer 24. For embodiments where plunger head 22 is a passivedevice, plunger head 22 may rely on the remote device to keep track ofthe date and time. By simplifying the functionality of plunger head 22the cost of manufacturing may be reduced.

In some embodiments, plunger head 22 may also include a crystaloscillator 32 configured to keep accurate time so that the date and timeof each injection may be accurately recorded and stored in memory ofmicrocontroller 26. Crystal oscillator may be, for example, a 32 KHZcrystal oscillator. In some embodiments, microcontroller 26 may includean internal RC oscillator, which may be calibrated using crystaloscillator 32. The internal RC oscillator may be, for example, a 10 MHZRC oscillator. Internal RC oscillator may provide sufficient timeaccuracy to measure the position (e.g., distance D) of plunger head 22to within, for example, about 150 microns. In some embodiments,transducer 24 may be used as an oscillator or as a calibrator for theinternal RC oscillator. In some embodiments, the frequency of the RCoscillator may be up-converted on microcontroller 26 to a higherfrequency. For example, the RC oscillator may be used to drive ahigher-frequency phase-locked loop.

Power source 28 may be any suitable power source. For example, powersource 28 may be a battery, a capacitor, or the like. In someembodiments, power source 28 may be rechargeable via wireless energytransmission, for example, inductive coupling, resonant inductivecoupling, radio frequency (RF) link, or the like. In some embodiments,power source 28 may be a non-rechargeable battery that is configured tolast the operational life of plunger head 22, for which the operationallife may be about 1 year, about 2 years, about 3 years, or more. Forexample, in some embodiments, power source 28 may be a watch battery. Insome embodiments, where plunger head 22 is a passive device as describedherein, power source 28 may be eliminated.

Antenna or transceiver 30 may be used to communicate with a variety ofremote devices (e.g., smart phones, glucose monitors, insulin pumps,computers, etc.). Plunger head 22 may transmit the information via anysuitable wireless communication method. For example, in someembodiments, plunger head 22 may utilize radio data transmission,BLUETOOTH or (BLE), (NFC), infrared data transmission or other suitablemethod. In some embodiments, information may also be wirelesslytransmitted from a remote device to plunger head 22 via antenna 30. Forexample, the date and time may be set by writing to microcontroller 26via the wireless communication.

In some embodiments, plunger head 22 may also include a force sensor 34.Force sensor 34 may be configured to detect when a force is applied toplunger head 22 via plunger 14, which for example may indicate thatdispensing of medication is going to be initiated. Force sensor 34 maybe, for example, a simple spring-loaded switch that is molded into theplunger head 22.

In some embodiments, plunger head 22 may be configured to only initiatesending and receiving of the ultrasonic signals 25 after force sensor 34has detected a force, which indicates dispensing is going to beinitiated. Prior to detecting the force, plunger head 22 may be in alow-power sleep state that is designed to conserve power (e.g., batterylife.) while still keeping accurate track of the date and time. In someembodiments, force sensor 34 may be configured to detect a force whenthe medication is being loaded or drawn into syringe 10 and causeplunger head 22 to “wake up.”

In some embodiments, transducer 24 may be configured to function as aforce sensor thereby eliminating the need for a separate force sensor34. For example, transducer 24 may have a piezoelectric element that maydetect the dynamic changes in pressure when a user depresses the plunger14.

In some embodiments, plunger head 22 may also include a temperaturesensor 36. Temperature sensor 36 may be configured to measure thetemperature of medication 20. Microcontroller 26 may be configured touse the temperature of medication 20 to compensate for variations in thetemperature that would affect the speed of sound within the medication,thus improving the accuracy of the distance and volume calculations.

In some embodiments, microcontroller 26 may also use temperature sensor36 to monitor the temperature of medication 20 to ensure that thetemperature of medication 20 stays within an acceptable range. Theefficacy of some medications is affected by temperature. For example,insulin is sensitive to hot and cold temperature. Plunger head 22 thusmay use temperature sensor 36 to monitor the temperature of medication20 and if the temperature of the medication 20 goes beyond theacceptable range then plunger head 22 may be configured to send analert. The type of alert may vary. In some embodiments, plunger head 22may include a display (not shown in FIG. 2) and the alert may be aflashing light or a visual indicator. In some embodiments, plunger head22 may include a speaker and the alert may be auditory, for example, abeeping sound. In some embodiments, the alert may be transmitted to aremote device and the remote device may display a visual alert and/orplay an auditory alert.

In some embodiments, plunger head 22 may also be configured to detectair bubbles in medication 20. Air bubbles if injected can be deadly sodetection of air bubbles is advantageous. In order to detect airbubbles, transducer 24 of plunger head 22 may be configured to detectsmall ultrasonic echoes created by the reflection of the ultrasonicwaves off the air bubbles in addition to the main echo caused by the endof barrel 12. Plunger head 22 may be configured to transmit an alert ifair bubbles are detected. The alert may be communicated in the same waysas the temperature alert described above.

In some embodiments, plunger head 22 may also be configured todifferentiate, verify, and/or identify medication 20 contained insyringe 10. For example, when barrel 12 is loaded with medication 20,plunger 14 and plunger head 22 may be pulled all the way back to itsstopping point and the distance from plunger head 22 to end 27 of barrel12 may be known enabling microcontroller 26 to solve for the speed ofsound of the fluid, which depends on temperature and density. Thetemperature may be measured by temperature sensor 36 so the density maybe determined and based on the density the amount of solids dissolved inthe fluid may also be determined. In addition, the viscosity of themedication 20 may be measured based on the amplitude of the reflectedultrasonic signals 25 because more viscous fluids dissipate more energy.In some embodiments, plunger head 22 may also include electrodes 38connected to microcontroller 26 configured to measure the conductivityof medication 20. In some embodiment, the electrodes 38 may protrude outfrom the surface of plunger head 22 into barrel 12 where the electrodes38 may contact medication 20. With the density, conductivity, andviscosity of medication 20 determined, microcontroller 26 may have asufficient number of properties to profile medication 20. In someembodiments, the profiling may be configured to differentiate medication20 in order to determine if it from a prescribed class of medication. Insome embodiments, the profiling may be configured to verify thatmedication 20 is the same as the medication that is prescribed for thepatient. In some embodiments, the profiling may be configured toidentify the medication 20.

According to an exemplary embodiment, plunger head 22 as describedherein may be combined with a syringe that has been modified to includea piezo linear motor. The piezo linear motor may be incorporated intothe wall of the barrel of the syringe and a piezo element may beincorporated into plunger head 22. The piezo linear motor may beconfigured to drive or “walk” the plunger head 22 down the barrel of thesyringe by driving the piezo element, thereby forcing the medicationfrom the syringe. This embodiment may enable the piezo linear motor tocontrol medication dispensing while plunger head 22 may simultaneouslytrack the amount of medication being dispensed. In some embodiments,plunger head 22 may control the piezo linear motor or plunger head 22can communication with a remote device that can control the piezo linearmotor such that it dispenses a set amount of medication.

FIG. 4 shows a smart syringe system 40, according to an exemplaryembodiment. System 40 may be designed for use with a standard disposablesyringe 10. Similar to plunger head 22, smart syringe system 40 may beconfigured to measure and register the quantity of medication 20administered and the date and time of administration. Smart syringesystem 40 may include a smart or intelligent plunger head 42, similar toplunger head 22, and a cuff 44. In some embodiments, plunger head 42 maybe designed to be disposable after a single use while cuff 44 isreusable. Embodiments of plunger head 42 designed to be disposable aftera single use may houses only the minimum number of components to carryout its function while any optional or ancillary components may behoused in cuff 44 to minimize manufacturing cost of plunger head 42. Themanufacturing cost of plunger head 42 may also be minimized by usinglower cost components (e.g., transducers, antennas, andmicrocontrollers) and materials (e.g., rubbers, polymers, plastics) thatare less robust and durable, and instead may be designed for shorteroperational life spans.

Plunger head 42 may be designed to be supplied with or installed into adisposable syringe 10 and after administering a dose of medication 20,syringe 10 along with plunger head 42 may be disposed of or recycled. Incontrast, cuff 44 may be designed to be reused numerous times. Forexample, a disposable syringe 10 may be inserted through cuff 44 andafter medication 20 is administered; cuff 44 may be removed from theused syringe 10 and be saved for later use.

In some embodiments, both plunger head 42 and cuff 44 may be reusable.For example, after medication 20 is administered by syringe 10, bothplunger head 42 and cuff 44 may be removed and saved for later use.

Plunger head 42 and cuff 44 can come in different sizes so they may beused with any size syringe. For example, plunger head 42 may be sized tofit within the barrel 12 of any size syringe 10 while cuff 44 may beconfigured to have a passage 46 configured to receive any size barrel 12of syringe 10.

Plunger head 42 and cuff 44 (i.e., the smart syringe system 40) incombination may be configured to have some or all of the same components(e.g., a transducer 24, a microcontroller 26, a power source 28, anantenna 30, crystal oscillator 32, force sensor 34, and a temperaturesensor 36) as plunger head 22 and perform at least all the sameoperations as plunger head 22. Some of the components may be housed inplunger head 42 while some of the components may be housed in cuff 44.To reduce the manufacturing cost of plunger head 42, as described above,plunger head 42 may be designed to house the minimum number ofcomponents to carry out its functions. For example, system 40 may beconfigured such that all the components that can be housed in cuff 44are, rather than plunger head 42. In some embodiments, such componentsmay include a form of memory for data storage.

According to an exemplary embodiment, plunger head 42 may include thetransducer 24, antenna 30, and a microcontroller 26 while cuff 44 mayalso include a separate microcontroller, a power source, and a separateantenna. To reduce complexity, plunger head 42 may be passive (e.g.,battery-free) and configured to be controlled and powered by cuff 44 viawireless energy transmission. Cuff 44 may also be configured tocommunicate with a remote device (e.g., a smart phone) thereby enablingthe volume of medication and the time and date of administering to beuploaded to another device or the cloud.

In some embodiments, cuff 44 may include a display. Cuff 44 may beconfigured to display any alerts (e.g., high temperature or impropermedication) to the user. Cuff 44 may also display the volume, date, andtime after medication has been dispensed. The display may also beconfigured to allow user input (e.g., touch screen). For example, theuser may program in the date, the time, the type of medication or otherinformation.

Plunger head 22 and system 40 described herein may be utilized for avariety of methods for tracking administering of a medication to apatient delivered by syringe. Various methods of utilizing plunger head22 and system 40 will now be explained with reference to FIG. 5. In someembodiments, the methods as described herein may be performed by acaregiver (e.g., a doctor or nurse) in a hospital or other inpatientsetting. In some embodiments, the methods as described herein may beperformed by a caregiver (e.g., a doctor, nurse, or parent) at home oroutside a hospital. In some embodiments, the methods as described hereinmay be performed by the patient. It is contemplated that the methodsdescribed herein may be performed in other settings by otherindividuals.

Plunger head 22 may be utilized for a method 100 of trackingadministering of a medication to a patient delivered by a syringe,according to an exemplary embodiment. In some embodiments, at step 102,method 100 may begin by installing plunger head 22 into the barrel 12 ofthe syringe 10 (e.g., a disposable syringe). In some embodiments, thesyringe 10 may be supplied with plunger head 22 already installed.

Next, at step 104, the barrel 12 of the syringe may be filled with themedication 20. The barrel 12 may be completely filled or only partiallywith medication 20. In some embodiments, the syringe 10 may be suppliedprefilled with medication 20. In some embodiments, plunger head 22 maybe configured to “wake up” in response to a force applied during thefilling, which may be detected by force sensor 34.

Once filled, at step 106, the syringe may then be positioned foradministration. For example, the needle may be inserted into the skin ofthe patient or into a drug delivery port connected to the patient. Oncein position, the plunger 14 of the syringe 10 may be depressed, whichforces plunger head 22 down the barrel 12 and forces the medication 20out the needle 16.

In some embodiments, the initial position of plunger head 22 (e.g., thedistance between plunger head 22 and end 27) may be known by plungerhead 22. For example, syringe 10 may be full and plunger head 22 mayknow the distance between plunger head 22 and end 27 when filled. Insome embodiments, if syringe 10 is used multiple times to deliver amedication 20, the previous position of plunger head 22 may be knownfrom the last measurement stored. In some embodiments, the initialposition of plunger head 22 may be measured using plunger head 22 priorto any medication 20 being delivered, as described below.

Prior to and while plunger 14 is being depressed, plunger head 22 maysend and receive ultrasonic signals 25 via transducer 24, at step 108.Plunger head 22 may send and receive ultrasonic signals 25 the durationof the time the plunger is being depressed. Plunger head 22 may measurea time it takes for each of the ultrasonic signals to travel through themedication to an end of the barrel and return to the transducer, at step110. In some embodiments, at least a portion of the ultrasonic signals25 may be sent and received before any medication 20 is dispensedenabling the initial position of plunger head 22 and initial volume ofmedication 20 to be calculated.

As described herein, at step 112, plunger head 22 may calculate thedistance the plunger head 22 travels over the course of dispensingmedication 20. At step 114, the quantity of medication 20 dispensed maybe calculated based on the calculated distance the plunger head 22traveled.

For some embodiments of method 100, the calculation of the quantity ofmedication dispensed may be performed by a remote device (e.g., a smartphone). In some embodiments, method 100 may also include transmittingthe quantity of the medication dispensed and the time and date thequantity was dispensed to a remote device. In some embodiments, method100 may also include uploading the quantity of the medication dispensedand the time and date the quantity was dispensed to the cloud. In someembodiments, method 100 may also include sending the quantity of themedication dispensed and the time and date the quantity was dispensed toa caregiver.

Although method 100 is described with reference to plunger head 22, itmay also be performed by system 40, as described herein.

The foregoing description has been presented for purposes ofillustration. It is not exhaustive and is not limited to precise formsor embodiments disclosed. Modifications and adaptations of theembodiments will be apparent from consideration of the specification andpractice of the disclosed embodiments. For example, the describedembodiments of plunger head 22, 42 and cuff 44 may be adapted for usedwith a variety of other medication injection devices, including forexample, auto-injectors, auto-syringes, injector pens (e.g., insulinpens), or other drug or medication injection devices.

Moreover, while illustrative embodiments have been described herein, thescope includes any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations and/or alterations based on the presentdisclosure. The elements in the claims are to be interpreted broadlybased on the language employed in the claims and not limited to examplesdescribed in the present specification or during the prosecution of theapplication, which examples are to be construed as nonexclusive.Further, the steps of the disclosed methods can be modified in anymanner, including reordering steps and/or inserting or deleting steps.

The features and advantages of the disclosure are apparent from thedetailed specification, and thus, it is intended that the appendedclaims cover all systems and methods falling within the true spirit andscope of the disclosure. As used herein, the indefinite articles “a” and“an” mean “one or more.” Similarly, the use of a plural term does notnecessarily denote a plurality unless it is unambiguous in the givencontext. Words such as “and” or “or” mean “and/or” unless specificallydirected otherwise. Further, since numerous modifications and variationswill readily occur from studying the present disclosure, it is notdesired to limit the disclosure to the exact construction and operationillustrated and described, and accordingly, all suitable modificationsand equivalents may be resorted to, falling within the scope of thedisclosure.

Computer programs, program modules, and code based on the writtendescription of this specification, such as those used by themicrocontrollers, are readily within the purview of a softwaredeveloper. The computer programs, program modules, or code can becreated using a variety of programming techniques. For example, they canbe designed in or by means of Java, C, C++, assembly language, or anysuch programming languages. One or more of such programs, modules, orcode can be integrated into a device system or existing communicationssoftware. The programs, modules, or code can also be implemented orreplicated as firmware or circuit logic.

Other embodiments will be apparent from consideration of thespecification and practice of the embodiments disclosed herein. It isintended that the specification and examples be considered as exampleonly, with a true scope and spirit of the disclosed embodiments beingindicated by the following claims.

1. A method of tracking administering of a medication delivered bysyringe, the method comprises: sending and receiving ultrasonic signalsfrom a plunger head installed within a barrel of the syringe in responseto depression of the plunger head; measuring the time it takes for thesignals to travel through the medication to an end of the barrel andreturn to the transducer; calculating the distance the plunger headtravels based on a change in the time; calculating a quantity of themedication dispensed based on the distance the plunger head travels; andselectively transmitting wirelessly the quantity of the medicationdispensed to a remote device.
 2. The method of claim 1, wherein theplunger head includes a force sensor and the depression of the plungeris detected by the force sensor and is used as an indication thatdispensing of the medication is beginning.
 3. The method of claim 1,further comprises uploading of the quantity of the medication dispensedand a time and a date the quantity was dispensed to a cloud where it issaved to a patient's medical history and is reviewed by a caregiver. 4.The method of claim 1, wherein the syringe is a standard disposablesyringe, and the method further comprises installing the plunger headinto the syringe prior to filing the barrel of the syringe.
 5. Themethod of claim 1, further comprises installing a cuff around thesyringe that communicates with and controls the plunger head.
 6. Themethod of claim 5, further comprises removing the cuff around thesyringe after the medication is dispensed and disposing of the syringean reusing the cuff with a second syringe.
 7. The method of claim 1,further comprising: measuring the conductivity of the medication usingthe plunger head; measuring the temperature of the medication using theplunger head; determining the density and of the medication using theultrasonic signals; and determining the viscosity of the medicationbased on an amplitude of the ultrasonic signals.
 8. The method of claim7, further comprising: profiling the medication based on theconductivity, the density, and the viscosity of the medication.
 9. Themethod of claim 8, further comprising transmitting the quantity of themedication dispensed, the time and date the quantity was dispensed, andthe profiling of the medication to a remote device.